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Tests treatment safety and results for Chemotherapy-induced Thrombocytopenia (CIT) in Patients...
Official title Efficacy and Safety of Hetrombopag in Preventing Chemotherapy-induced Thrombocytopenia in Gastrointestinal Tumors
ClinicalTrials.gov ID: NCT07492693
What this study is testing
What is Hetrombopag?
Hetrombopag is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chemotherapy-induced thrombocytopenia (cit) in patients with gastrointestinal tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This trial is a single-arm, prospective clinical study aimed at evaluating the efficacy and safety of hetrombopag in preventing chemotherapy-induced thrombocytopenia (CIT) in patients with gastrointestinal tumors. The study plans to enroll 40 patients with gastrointestinal tumors who develop thrombocytopenia due to chemotherapy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- age ≥18 years;
- pathologically confirmed gastrointestinal tumors (including esophageal cancer, gastric cancer, colorectal cancer, etc.);
- during the previous chemotherapy cycle (N-1 cycle), patients had a minimum platelet count of ≥75×10⁹/L and at least one high-risk bleeding factor (①...
- during the current chemotherapy cycle (N cycle), patients have a platelet count of ≥100±25×10⁹/L;
- undergoing treatment cycles of 14 or 21 days and requiring at least one more cycle of therapy.
You likely can't join if
- Previous use of TPO-RA drugs;
- Pre-treatment conditions that cause thrombocytopenia, such as hypersplenism or immune thrombocytopenia;
- History of thrombosis;
- Hematologic diseases (anemia, leukemia, autoimmune hemolytic diseases, etc.);
- Major cardiovascular diseases (acute myocardial infarction, cerebral thrombosis, cerebral hemorrhage, etc.);
- Pregnant or breastfeeding women;
See the full eligibility criteria
- age ≥18 years;
- pathologically confirmed gastrointestinal tumors (including esophageal cancer, gastric cancer, colorectal cancer, etc.);
- during the previous chemotherapy cycle (N-1 cycle), patients had a minimum platelet count of ≥75×10⁹/L and at least one high-risk bleeding factor (① history of bleeding; ② previous treatment with platinum agents...
- during the current chemotherapy cycle (N cycle), patients have a platelet count of ≥100±25×10⁹/L;
- undergoing treatment cycles of 14 or 21 days and requiring at least one more cycle of therapy.
- ECOG score: 0-2 points;
- Adequate hematopoietic, liver, and kidney function:
- Neutrophil count ≥ 1.5 x 10⁹/L
- Hemoglobin ≥ 9.0 g/dL
- Creatinine clearance ≥ 40 mL/min (Cockcroft-Gault formula)
- For patients without liver metastasis, AST and ALT ≤ 2.5 times the upper limit of normal;
- Bilirubin ≤ 2 times the upper limit of normal;
- APTT and PT ≤ 1.5 times the upper limit of normal
- Signed informed consent form.
- Previous use of TPO-RA drugs;
- Pre-treatment conditions that cause thrombocytopenia, such as hypersplenism or immune thrombocytopenia;
- History of thrombosis;
- Hematologic diseases (anemia, leukemia, autoimmune hemolytic diseases, etc.);
- Major cardiovascular diseases (acute myocardial infarction, cerebral thrombosis, cerebral hemorrhage, etc.);
- Pregnant or breastfeeding women;
- Participation in other drug clinical trials within 4 weeks;
- Poor compliance, unable to cooperate or report treatment responses;
- Need for other antiplatelet or platelet-enhancing drugs, including traditional Chinese medicine and herbal preparations;
- Use of prior platelet-stimulating drugs within 5 half-lives before first dose;
- Platelet transfusion within 3 days before first dose.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.